Kornimate/medical-research-clean huggingface dataset:
exploring and establishment of combined extracorporeal life support(cels) in critically ill children

Conditions: Sepsis; Critical Illness; MODS

Summary: multiple organ failure (mods) is still the leading cause of death in children in icu. the treatment of mods is mainly organ function monitoring and organ replacement therapy. life support technology in vitro mainly includes mechanical ventilation, continuous renal replacement therapy (crrt), non-biological artificial liver and extracorporeal membrane oxygenation technology (ecmo). however, critically ill patients who have multiple organ failure often require multiple organ support meanwhile. combined extracorporeal life support (cels) is still in its infancy to be applied in the treatment of critical illness due to nonstandard technology and theory without key breakthroughs and evidence-based medicine in the treatment of severe children organ failure.solving the system problems supported by cels can effectively reduce the mortality and disability rate of critically ill children and enhance health care in shanghai, even across china.

the whole study is described below. to investigate the timing ,curative effect and mode of crrt and ecmo treatment for critically ill children,we choose sepsis children especially those who are combined with septic shock as research object. furthermore,refractory shock is the therapeutic indications of ecmo. according to their clinical manifestation and severity of the disease,they are treated by crrt or/with ecmo in a non-randomized way. comparing the laboratory index and prognosis of critically ill children treated by crrt and those treated by ecmo,we aim to investigate the the timing ,curative effect of ecmo in the treatment of septic shock especially refractory shock. the critically ill children who treated by crrt are divided into three groups according to their treatment mode of crrt. the laboratory index and prognosis are also be compared to investigate curative effect of crrt in the treatment of septic shock. the study also include severe sepsis children without crrt or ecmo treatment as a control group.

Eligibility criteria:
inclusion criteria: * children with severe sepsis and refractory shock admitted to the picu of four study centers. the informed consent of the guardians exclusion criteria: * active hemorrhage difficult catheter placing irreversible brain damage patients enrolled in other clinic trial

Keywords: sepsis crrt ecmo cels
evaluation of the dietary supplement refill bypass to reduce nutritional deficiencies of patients who underwent bariatric surgery

Conditions: Obesity; Bariatric Surgery

Summary: this is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months. this observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. data collection will be carried out during routine visits planned in the post-operation usual follow-up. the blood tests are part of the patient's usual care for his bariatric surgery. surgeons will include patients for whom they have freely decided to use the dietary supplement refill under the care of the treatment of obesity. the motivation of the patient and his commitment to the project is evaluated by the surgeon. the main objective is to evaluate the efficacy of the dietary supplement refill. the primary endpoint is the reduction of iron deficiency.


Eligibility criteria:
inclusion criteria: * patient with a scheduled bariatric surgery "gastric bypass", * patient who performed a blood test before surgery, * patient compliant. exclusion criteria: * allergy to components of the dietary supplement, * pregnancy or breastfeeding, * any biological abnormality considered by the investigator significant.
hemago monitoring and impact on the occurrence of complications during pregnancy in sickle cell patients

Conditions: Sickle Cell Disease and Pregnancy

Summary: sickle cell disease is the most common monosemic genetic disease in the world and affects approximately 32,000 people in france. in recent years, improvements in the management of this pathology have led to a steady increase in the life expectancy of sickle cell patients. women with sickle cell disease are increasingly likely to have one or more pregnancies. several studies have shown that these pregnancies are marked by maternal morbidity due to acute sickling crises, thromboembolism, infection, chronic end-organ dysfunction, or pre-eclampsia (pe), while neonatal outcomes may be intrauterine growth retardation (iugr), preterm delivery, small infants for gestational age, stillbirth, and neonatal death. consequently, monitoring pregnancies in sickle cell patients represents a complex medical challenge due to the risk of potentially serious maternal and fetal complications. multidisciplinary follow-up is then crucial to monitor and manage these possible complications. the double hematologist-obstetrician consultation program (hemago) offers complete and adapted close follow-up, in order to minimize the risks for the mother and the unborn child. this study aims to evaluate the impact of this hemago monitoring on the various maternal and obstetric complications by comparing the outcome of pregnancies of patients who were followed before the implementation of this device to patients who were followed in the frame their pregnancy through this program.


Eligibility criteria:
inclusion criteria: * sickle cell disease female * followed up for at least one pregnancy in the maternity of croix-rousse hospital, femme mère enfant hospital and lyon sud hospital exclusion criteria: * minor woman

Keywords: sickle cell disease ; genetic disease ; anemia ; pregnancy ; obstetrics complications
impact of echocardiography on management of critically ill neonates

Conditions: Critical Illness; Echocardiography; Neonatology

Summary: the goal of the study was to estimate the outcome (mortality and morbidity) among hemodynamically unstable neonates, as well as the time to return to hemodynamic stability following the use of echo in the management of hemodynamically unstable neonates.

-all patients will be subjected to : full clinical examination for manifestation or signs of hemodynamic instability and daily thereafter until discharge. an echocardiographic assessment using vivid t8 pro ( ge medical systems ( china ) co, ltd.) is done if manifestations of hemodynamic instability or shock appeared. the imaging planes were identified by transducer location (subxiphoid, apical, parasternal, suprasternal notch, and right parasternal). the segmental approach was used to describe all of the major cardiovascular structures in sequence. suggested plan of management will be as the following: 1. neonates with low lvo and impaired left ventricular contractility: dobutamine at a dose of 5-20 μg/kg/min was given, and if no improvement, volume expansion as a single intravenous infusion of 10-20 ml/kg of the crystalloid solution was given. if still no improvement, hydrocortisone at a dose of 1 mg/kg every 4 h was added. if improvement was not achieved, epinephrine was added at a dose of 0.05-2.6 μg/kg/min \[11\]. 2. neonates with lvo and hypovolemia (under-filled left ventricle): volume expansion as a single intravenous infusion of 10-20 ml/kg of the crystalloid solution will be given. if still no improvement, it was repeated \[11\]. 3. neonates with normal or high lvo without pda: dopamine at a dose of 5-20 μg/kg/min is given. if no improvement, hydrocortisone at a dose of 1 mg/kg every 4 h is added. if improvement was not achieved, epinephrine is added at a dose of 0.05-2.6 μg/kg/min \[11\]. 4. neonates with normal or high lvo and hemodynamically significant pda: pda will be treated either medically or surgically \[11\]. 5. during the current study period, all previously mentioned hemodynamically unstable neonate values were compared to values collected from the controlled group (200 hemodynamically stable neonates). 6. neonates will be monitored regularly and subjected to repeated echocardiographic and clinical examinations to detect clinical and laboratory findings suggestive of hemodynamic instability or shock.

Eligibility criteria:
inclusion criteria: * all neonates ( age 0 to 28 days) admitted to the nicu of sohag university hospital during the period of the study in whom manifestations of hemodynamic instability or critical illness were elected regardless of gestational age, weight, gender, or type of disease. exclusion criteria: * failure to obtain informed consent . * presence of congenital heart disease apart from pda , pfo \& small asd .
safety of pentaxim® given as a three-dose primary vaccination at 2, 3, and 4 months of age in infants in china

Conditions: Diphtheria; Tetanus; Pertussis; Polio

Summary: the study will assess the safety of pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in china, and to generate additional clinical data using the three-dose primary vaccination schedule in some other chinese provinces. primary objective * to describe the safety after administration of pentaxim® at 2, 3, and 4 months of age in the study population.

each study participant will receive an injection of pentaxim® at 2, 3, and 4 months of age and will be monitored for safety through the entire study period. the duration of each participant in the trial will be approximately 3 to 4 months.

Eligibility criteria:
inclusion criteria: * aged 2 months (60 to 74 days) inclusive on the day of the first study visit * informed consent form has been signed and dated by the parent(s) or other legally acceptable representative * subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) * known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion * evolving encephalopathy * receipt of immune globulins, blood or blood-derived products since birth * previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or haemophilus influenzae type b infection * receipt of any other vaccine in the 14 days preceding the first trial vaccination or planned receipt of any vaccine in the 14 days following the first trial vaccination * acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥37.1°c). a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. * contraindications to vaccination according to pentaxim® summary of product characteristics (spc) or leaflet * in an emergency setting, or hospitalized involuntarily * identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study.

Keywords: pentaxim® whole-cell pertussis vaccine acellular pertussis vaccine haemophilus influenzae type b polysaccharide inactivated polio vaccine pentavac®
ruby post-market registry on the jada® system

Conditions: Postpartum Hemorrhage

Summary: the ruby study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the jada system in the post-market setting.

the purpose of this registry is to collect observational data on patients treated with the jada system in the post-market setting. data collection will include observations of effectiveness and safety of the device. additional outcome data related to resource utilization will also be included.

Eligibility criteria:
inclusion criteria: • use of the jada system (inserted into the patient and connected to vacuum). note: there is no exclusion criteria in this protocol.

Keywords: vacuum-induced hemorrhage-control (vhc) jada postpartum hemorrhage
an investigational immuno-therapy study of temozolomide plus radiation therapy with nivolumab or placebo, for newly diagnosed patients with glioblastoma (gbm, a malignant brain cancer)

Conditions: Brain Neoplasms

Summary: the purpose of this study is to evaluate patients with glioblastoma that is mgmt-methylated (the mgmt gene is altered by a chemical change). patients will receive temozolomide plus radiation therapy. they will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * males and females, age ≥ 18 years old * newly diagnosed brain cancer or tumor called glioblastoma or gbm * karnofsky performance status of ≥ 70 (able to take care of self) * substantial recovery from surgery resection * tumor test result shows mgmt methylated or indeterminate tumor subtype exclusion criteria: * biopsy-only of gbm with less than 20% of tumor removed * prior treatment for gbm (other than surgical resection) * any known tumor outside of the brain * recurrent or secondary gbm * active known or suspected autoimmune disease other protocol defined inclusion/exclusion criteria could apply
a study to evaluate the long-term safety of idecabtagene vicleucel treatment in adults with newly diagnosed multiple myeloma in korea

Conditions: Multiple Myeloma

Summary: the purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the karmma-9 (ca089-1043) phase 3 clinical trial.


Eligibility criteria:
inclusion criteria: * adult participants ≥19 years of age * korean participants with newly diagnosed multiple myeloma who had a suboptimal response after autologous stem cell transplantation (asct) and who were treated with idecabtagene vicleucel (assigned to arm a) in the karmma-9 trial (ca089-1043) * participants must understand and voluntarily sign and informed consent form (icf) for the korea long-term follow-up surveillance study prior to any surveillance-related procedures being conducted exclusion criteria: * participants who participate in karmma-9 trial (ca089-1043) but disagree with long-term follow-up surveillance in korea * participants who are not possible to treat with ide-cel within 9 days post-completion of lymphodepleting chemotherapy (ldc), if delays occur. however, depending on the participants recovery status, whether idecabtagene vicleucel is administered or not, should be discussed with a medical monitor

Keywords: multiple myeloma
evaluation of choledochoduodonostomy vs hepaticojejunostomy in paients with choledocholithiasis indicated for shunt.

Conditions: Recurrent Common Bile Duct Stones

Summary: a biliary-enteric anastomosis can be needed for a number of indications, including malignant or pre-malignant biliary diseases, benign biliary stenosis, bile duct injury, and complex choledocholithiasis. choledochoduodenostomy is the most simple form of biliary-digestive anastomosis, with only minimal alteration to the normal anatomy. due to the reported specific complications of choledochoduodenostomy, such as sump syndrome and gastritis caused by biliary reflux, creation of a hj was preferred in the past decades . a roux-en-y hepaticojejunostomy (hj) does not cause sump syndrome and only rarely reflux gastritis, but the procedure is more extensive, requiring an additional jejuno-jejunostomy .especially for patients with extensive intra-abdominal adhesions or with a history of small bowel resections, the creation of a roux-en-y limb might pose a problem. some recent publications have concluded that cd leads to acceptable surgical outcome, with low reported incidences of sump syndrome and reflux gastritis. however, these studies do not make a direct comparison between cd and hj. especially comparisons of long-term outcomes between cd and hj are lacking.

there are 2 options are available: choledochoduodonostomy or roux-en-y choledochojejunostomy. both can be accomplished via a laparoscopic approach; however, thereis no consensus to which is best due to a paucity of data comparing the techniques. choice of operation is largely left up to the individual surgeon. athough performed infrequently for benign biliary disease, biliary bypass operations are fundamental for any surgeon and are considered a core operation by the american college of surgeons for any general surgery resident. in our study we are going to describe in detail our technique and outcomes when used for choledocholethiasis.

Eligibility criteria:
inclusion criteria: residual stones. recurrent stones, failed ercp due to imacted large stone, multiple cbd calculi with distal narrowing (funnel syndrome), papillary stenosis; impacted calculi, biliary sludge-symptomatic, sphincter of oddi dysfunction/stenosis, primary cbd stones; previous choledochotomy and marked cbd dilatation. exclusion criteria: surgically unfit patients, malignancy, infections e.g, cholangitis and coagulation disorders.

Keywords: choledochoduodonostomy hepaticojejunostomy choledocholithiasis
energy expenditure pre and post bariatric surgery

Conditions: Bariatric Surgery

Summary: obese patients are going to be submitted to indirect calorimetry pre-operatively and we are going to repeat the same exam 6 months after bariatric surgery (post roux-en-y gastric bypass surgery). they are going to do also body composition analysis in both moments. the investigators are going to compare the results to see if the bariatric surgery increases their energy expenditure.


Eligibility criteria:
inclusion criteria: * obese patients that will be submitted to bariatric procedure exclusion criteria: * patients that don´t have clinical conditions to be submitted to a bariatric procedure

Keywords: energy expenditure morbid obesity bariatric surgery nutritional follow-up
effect of cervical multifidus muscle area on interlaminar epidural steroid injection outcomes

Conditions: Cervical Radiculopathy

Summary: cervical radiculopathy is one of the most important causes of chronic neck pain. cervical epidural steroid injections including interlaminar approach are frequently used for treatment option in patients that more conservative modalities are ineffective. paraspinal muscles have an important role in supporting neck movements and providing stability of the cervical spine. the multifidus muscle, located in the deepest part of the neck extensor muscle group, has become the muscle that is frequently emphasized in spinal pain in recent years. in the literature, it has been shown that the multifidus muscle on the affected side is atrophied in patients with cervical radiculopathy. although many factors are known to be effective on the outcomes of cervical interlaminar epidural injection, there are limited data on the effect of the multifidus muscle area. in this retrospective study, it was planned to investigate the effect of the multifidus muscle area on the results of cervical interlaminar epidural steroid injection.


Eligibility criteria:
inclusion criteria: * patients with unilateral radicular pain due to cervical disc herniation for at least 3 months * patients with disc herniation level c5-c6 * patients who are unresponsive to other conservative treatments and who have undergone cervical interlaminar epidural steroid injection exclusion criteria: * patients with incomplete medical records (absence of mr imaging, incomplete data of 3rd week and 3rd month follow-up periods after cervical interlaminar epidural steroid injection)
efficacy of fructose metabolizing enzymatic product in fructose malabsorption

Conditions: Fructose Malabsorption

Summary: the purpose of this study is to determine whether the enzymatic product frucosin(r) is able to degrade fructose in vivo in the small intestine of patients with known fructose malabsorption by measuring hydrogen in the expiratory air.

fructose malabsorption is a digestive disorder in which the uptake of fructose in the small intestine is deficient. this leads to an increase of the concentration of fructose in the large intestine after the intake of fructose-rich meals. the exzess fructose is then degraded by intestinal microbes into co2, ch4, h2 and short chain fatty acids causing symptoms like bloating, diarrhea, flatulence or stomach pain. the clinical diagnosis requires a hydrogen breath test after challenge with fructose. after an oral challenge with fructose the emerging hydrogen is measured in the expiratory air. a fructose malabsorption is diagnosed if the hydrogen in the expiratory air reaches 20ppm or more. in the course of this study the participants will take 2 hydrogen breath tests. before each of these tests the participants will take either the active treatment (fructosin(r)) or a placebo. the active treatment should reduce the exhaled hydrogen indicating a reduced concentration of fructose in the large intestine after fructose metabolization by the verum.

Eligibility criteria:
inclusion criteria: * diagnosed fructose malabsorption exclusion criteria: * gravidity * diabetes mellitus * recent gastrointestinal surgery * recent endoscopy * recent antibiotics therapy
implementation toolkit to enhance ebp among marginalized families

Conditions: Autism; Early Intervention

Summary: although the efficacy of early intervention (ei) for autistic children and their families has been established, many marginalized families with diverse cultural and linguistic backgrounds still report inequitable access to evidence-based practices (ebp). there are several strategies to increase ebp implementation that are especially relevant to marginalized families who report inequitable access to coaching from ei providers, such as increasing the capacity of ei providers to coach families in a culturally responsive way. however, ei providers are provided with limited professional development in both family coaching and cultural responsiveness, which results in perpetuation of ebp implementation failure. thus, it is crucial to develop and validate an implementation toolkit that comprises strategies to enhance cultural responsiveness in the uptake of ebps among ei providers. therefore, the overall purpose of this research is to identify facilitators and barriers of ebp implementation among marginalized families in ei to aid the development an implementation toolkit with a focus on capacity building of ei providers to implement ebp with cultural responsiveness. this will involve conducting individual interviews with ei providers.


Eligibility criteria:
there are two sets of inclusion criteria for both types of participants. inclusion criteria for ei providers: * currently working with minoritized families of young children within part-c * willing to complete i-team as instructed * over the age of 18 exclusion criteria for ei providers: * not able to complete i-team as instructed inclusion criteria for families: * having a minoritized backgrounds (e.g., migrant/refugee background, primarily speaks another language other than english at home) * having a young child eligible for early intervention services exclusion criteria for ei providers: * not currently receiving early intervention services